Skip to content

Evaluation of clinical value of a standardized protocol for dose reduction in patients with axial Spondyloarthritis and clinical remission with anti-TNF therapy

Evaluation of clinical value of a standardized protocol for dose reduction in patients with axial Spondyloarthritis and persistent clinical remission with anti-TNF therapy: Open-label, controlled, randomized, multicenter trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2011-005871-18-ES
Enrollment
Unknown
Registered
2011-12-21
Start date
2012-04-03
Completion date
Unknown
Last updated
2015-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Axial Spondyloarthritis

Interventions

Trade Name: HUMIRA Product Name: ADALIMUMAB Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB CAS Number: 331731-18-1 Current Sponsor code: n/a Concentr

Sponsors

CLINICAL PHARMACOLOGY SPANISH SOCIETY
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 190 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Main Objective: To demonstrate that patients with espondilartritis in remission under antiTNF therapy can maintain the remission with a maintenance dose inferior to the currently recommended dose schedule;Secondary Objective: ;Primary end point(s): FALTA TEXTO INGLES;Timepoint(s) of evaluation of this end point: 1 YEAR

Secondary

MeasureTime frame
Secondary end point(s): FALTA TEXTO INGLES;Timepoint(s) of evaluation of this end point: 1 and 2 years

Countries

Spain

Contacts

Public ContactCRISTINA AVENDAÑO-SOLÁ

CLINICAL PHARMACOLOGY DEPARTMENT- UNIVERSITARY HOSPITAL "PUERTA DE HIERRO"

cavendano.hpth@salud.madrid.org34911916479

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Mar 15, 2026